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EP Device Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04460209
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
This study will provide ongoing, high quality data on the safety, performance, and clinical benefits of Abbott's EP devices in a real-world setting.

Condition or disease Intervention/treatment
Cardiac Rhythm Disorder Other: Standard of Care

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 7500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: EP Device Registry
Actual Study Start Date : June 12, 2020
Estimated Primary Completion Date : November 2030
Estimated Study Completion Date : December 2031

Intervention Details:
  • Other: Standard of Care
    Standard of care mapping and/or ablation


Primary Outcome Measures :
  1. The proportion of patients with a device- and/or procedure-related Serious Adverse Event [ Time Frame: 7-days ]
    that occurred within 7-days of the procedure.

  2. The proportion of procedures that achieved acute success. [ Time Frame: Baseline ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Male and female subjects of all ages who underwent an electrophysiology (EP) imaging (diagnostic procedure) and/or ablation procedure that used at least one Abbott device covered by this Registry.
Criteria

Inclusion Criteria:

  • Subject underwent an electrophysiology imaging (diagnostic procedure) and/or ablation procedure that used one or more Abbott devices covered by this Registry.
  • Subject is willing and able to comply with the site's standard of care follow-up schedule.

Exclusion Criteria:

  • Subject is currently participating in another clinical investigation that may confound the results of this Registry.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04460209


Contacts
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Contact: Maxime De Groof, MPH +3227746859 Maxime.degroof@abbott.com
Contact: Anne Sarver, PhD +16517563813 anne.sarver@abbott.com

Locations
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Italy
Ospedale dell'Angelo Recruiting
Mestre, Veneto, Italy, 30174
Contact: Paolo China, MD       paolo.china@aulss3.veneto.it   
Portugal
Hospital de São João Recruiting
Porto, Portugal, 4202-451
Contact: Liliana Meneses, Tech       meneses.liliana87@gmail.com   
Spain
Hospital de Navarra Recruiting
Pamplona, Navarre, Spain, 31008
Contact: Alicia Gainza Calleja, BN    +34848423320    alicia.gainza.calleja@navarra.es   
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Director: Kristin Ruffner, PhD Abbott
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT04460209    
Other Study ID Numbers: ABT-CIP-10316
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes